ENTERIC COATED FLUOXETINE COMPOSITION

摘要

An enteric coated composition of fluoxetine (N-metthyl- (p-trifluoromethylphenoxy)-3-phenylpropylamine) in the form of coated tablets and pellets providing gastric pH resistance but disintegrating rapidly in intestinal. The composition is suitable for oral administration comprising a core consisting of the active fluoxetine and/or its pharmaceutically acceptable acid addition salts along with one or more pharmaceutically acceptable excipients with a selective seal coat on said core and an enteric coat over said seal coated core. A seal coat of polyvinyl alcohol is proposed over which an enteric coat of methacrylic acid copolymer is provided. The above enteric coated formulations of fluoxetine involve a cheaper, commercially available, easier to apply enteric polymer wherein smaller quantities of polymer are required to achieve the desired results. It would provide enteric coated formulation of fluoxetine requiring smaller quantities of polymer and yet achieve the desired characteristics of gastric pH resistant to release and rapidly disintegrating release profile in intestine pH.